PYC pyc therapeutics limited

Just as the FDA is about to commence its two day meeting to...

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    Just as the FDA is about to commence its two day meeting to evaluate the safety risks of gene therapy, Astellas Pharma has announced that it has once again halted dosing in its trial of AT132 gene therapy for X-linked myotubular myopathy after the occurrence of another serious adverse event linked to possible liver damage.

    The Astellas trial was already placed under a clinical hold by the FDA last December after deaths related to liver dysfunction were reported for three patients treated with a high dose.

    The halt in the Astellas trial comes just over a month after Adverum announced the scrapping of its ocular gene therapy development program, ADVM-022 in diabetic macular edema, after several patients who received higher doses in a Phase 2 trial suffered serious adverse events, including loss of vision.

    https://www.biopharmadive.com/news/fda-gene-therapy-advisory-meeting-safety-preview/605922/

    https://pharmaphorum.com/news/more-...tm_campaign=Feed: pharmaphorum (pharmaphorum)

    https://hotcopper.com.au/threads/an...5666198/page-29?post_id=54742946#.YS_3op1LiUk
 
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